Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study.
Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study.
复制标题
慢性偏头痛预防伴随着非侵入性迷走神经刺激：事件研究。
DOI：
10.1212/wnl.0000000000002918
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发表时间：
2016-08-02
期刊：
影响因子：
9.9
通讯作者：
EVENT Study Group
中科院分区：
文献类型：
--
作者：
Silberstein SD;Calhoun AH;Lipton RB;Grosberg BM;Cady RK;Dorlas S;Simmons KA;Mullin C;Liebler EJ;Goadsby PJ;Saper JR;EVENT Study Group
评估无创迷走神经刺激 (nVNS) 用于预防慢性偏头痛 (CM) 发作的可行性、安全性和耐受性。在这项第一项关于 nVNS 在 CM 预防中的前瞻性、多中心、双盲、假对照试点研究中，患有 CM（≥15 次头痛 d/mo）的成人进入基线期（1 个月），随后在接受开放标签 nVNS 治疗（6 个月）之前随机接受 nVNS 或假治疗（2 个月）。主要终点是安全性和耐受性。意向治疗人群的疗效终点包括每 28 天头痛天数的变化和急性药物使用。 59 名参与者（平均年龄，39.2 岁；平均头痛频率，21.5 天/月）被纳入。在随机阶段，nVNS (n = 30) 和假治疗 (n = 29) 的耐受性相似。大多数不良事件是轻度/中度且短暂的。头痛天数的平均变化为-1.4（nVNS）和-0.2（假手术）（Δ = 1.2；p = 0.56）。二十七名参与者完成了开放标签阶段。对于最初分配至 nVNS 的 15 名完成者，治疗 8 个月后头痛天数相对于基线的平均变化为 -7.9（95% 置信区间 -11.9 至 -3.8；p < 0.01）。 nVNS 治疗耐受性良好，没有安全问题。持续预防性使用可能会减少 CM 中头痛的天数；需要更大规模的假对照研究。 NCT01667250。这项研究提供了 II 类证据，表明对于 CM 患者，nVNS 是安全的，耐受性良好，并且不会显着改变头痛天数。这项试点研究缺乏精确性，无法排除 nVNS 的重要安全问题或益处。
To evaluate the feasibility, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS) for the prevention of chronic migraine (CM) attacks. In this first prospective, multicenter, double-blind, sham-controlled pilot study of nVNS in CM prophylaxis, adults with CM (≥15 headache d/mo) entered the baseline phase (1 month) and were subsequently randomized to nVNS or sham treatment (2 months) before receiving open-label nVNS treatment (6 months). The primary endpoints were safety and tolerability. Efficacy endpoints in the intent-to-treat population included change in the number of headache days per 28 days and acute medication use. Fifty-nine participants (mean age, 39.2 years; mean headache frequency, 21.5 d/mo) were enrolled. During the randomized phase, tolerability was similar for nVNS (n = 30) and sham treatment (n = 29). Most adverse events were mild/moderate and transient. Mean changes in the number of headache days were −1.4 (nVNS) and −0.2 (sham) (Δ = 1.2; p = 0.56). Twenty-seven participants completed the open-label phase. For the 15 completers initially assigned to nVNS, the mean change from baseline in headache days after 8 months of treatment was −7.9 (95% confidence interval −11.9 to −3.8; p < 0.01). Therapy with nVNS was well-tolerated with no safety issues. Persistent prophylactic use may reduce the number of headache days in CM; larger sham-controlled studies are needed. NCT01667250. This study provides Class II evidence that for patients with CM, nVNS is safe, is well-tolerated, and did not significantly change the number of headache days. This pilot study lacked the precision to exclude important safety issues or benefits of nVNS.